Active substanceTerazozinTerazozin
Similar drugsTo uncover
  • Kornam
    pills inwards 
    Lek dd     Slovenia
  • Setegis®
    pills inwards 
  • Terazozin
    pills inwards 
  • Terazozin
    pills inwards 
    REPLEK FARM Skopje, OOO     Macedonia
  • Terazozin-Teva
    pills inwards 
  • Dosage form: & nbsppills
    Composition:

    each tablet contains, respectively, 1 mg, 2 mg, 5 mg or 10 mg of the active ingredient terazosin (in the form of terazosin hydrochloride dihydrate 1,187 / 2,374 / 5,935 / 11,87 mg).

    Excipients: lactose monohydrate 55/110/110/110 mg, pregelatinized corn starch 20/40/40/40 mg, povidone K-30 2,5/5/515 mg, magnesium stearate 1/2/2/2 mg, talc 1/2/2/2 mg; tablets of 2 mg also contain a quinoline yellow dye of 0.05 mg, and tablets of 5 mg and 10 mg contain a sunset sunset yellow dye of 0.01 mg and 0.1 mg, respectively.

    Description:

    Tablets 1 mg: Round flat tablets of white color, with a facet, with engraving Е 451 on one side of the tablet, odorless.

    Tablets 2 mg: Round flat tablets of yellow color (the heterogeneity of coloring is possible), with a facet, with engraving Е 452 on one side of the tablet, odorless.

    Tablets 5 - mg: Round flat pills of light pink color (the heterogeneity of coloring is possible), with a facet, with engraving Е 453 on one side of a tablet, without a smell.

    Tablets 10 mg: Round flat tablets of light orange color (the heterogeneity of coloring is possible), with a facet, with engraving Е 454 on one side of a tablet, without a smell.

    Pharmacotherapeutic group:alpha-1-adrenoblocker
    ATX: & nbsp

    G.04.C.A.03   Terazozin

    Pharmacodynamics:

    Antagonists α1-adrenergic receptors improve urodynamics in patients with benign prostatic hyperplasia (BPH). Symptoms of BPH are associated with an increase in the tone of the smooth muscles of the output part of the bladder (triangle and neck of the bladder, the proximal part of the urethra) and the prostate that controls α1-adrenergic receptors. In vitro, terazosin - inhibited contractions of the smooth muscles of the human prostate caused by phenylephrine. In clinical trials terazosin improved urodynamics and eliminated symptoms in patients with BPH.

    Terazosin expands arteries due to competitive antagonism in relation to postsynaptic αladrenoreceptors. Terazozin causes a gradual decrease in blood pressure (BP) followed by a prolonged antihypertensive effect.

    Terazosin in therapeutic doses reduces total blood cholesterol by 2-5% andthe sum of concentrations of low-density lipoprotein cholesterol (LDLP) and very low density lipoprotein cholesterol (CHLP) in blood by 3-7% compared to pre-treatment. In addition, an increase in the total cholesterol level noted against the administration of other antihypertensive drugs was not observed if, in combination with them, terazosin.

    Pharmacokinetics:

    Terazosin is quickly and almost completely absorbed from the gastrointestinal tract, regardless of food intake. Has a very small effect of the first passage through the liver. Its bioavailability is close to 90%. Terazozin to a great extent (90- 94%) binds to blood plasma proteins. Metabolised in the liver, of the four known metabolites, only one pharmacologically active. The elimination half-life is approximately 12 hours without significant changes even if the kidney function is impaired. Terazozin begins to act about 15 minutes after the introduction of a single dose, the maximum concentration in the blood plasma is reached within 1 hour, and the maximum effect occurs 2-3 hours after ingestion. Duration of action 24 hours.Approximately 40% of the accepted dose is excreted by the kidneys and 60% by the intestine. The kidney function does not affect the excretion of the drug.

    Indications:

    Symptomatic treatment of benign prostatic hyperplasia (BPH).

    Arterial hypertension (as a monotherapy or in combination with other antihypertensive drugs)

    Contraindications:

    Hypersensitivity to the active substance or to any other structural analogues of alpha-adrenergic antagonists, or to excipients, arterial hypotension, lactation period, children's age (due to lack of sufficient clinical data).

    Carefully:Angina pectoris, ischemic heart disease or heart failure in the stage of decompensation, renal / hepatic insufficiency, cerebral circulation disorder, type I diabetes mellitus.
    Pregnancy and lactation:

    Due to the lack of clinical data for the use of terazosin during pregnancy and lactation, it is only possible to use the drug during pregnancy if the potential benefit to the mother exceeds the risk to the fetus. If you need to use the drug during lactation, breastfeeding should be discontinued.

    Dosing and Administration:

    Tablets are taken orally. The tablet should be swallowed completely without chewing. The daily dose of the drug should be selected individually, depending on the blood pressure in the patient.

    Initial dose for adults:

    For both indications, take 1 mg before bedtime. The initial dose should not be above 1 mg due to the increased risk of episodes of hypotension after taking the first dose. The daily dose can be gradually increased, roughly doubling the dose at weekly intervals until the target blood pressure level is reached. Maintenance dose for adults:

    Arterial hypertension: Usually from 2 mg to 10 mg once a day. Doses of more than 20 mg rarely improve the effectiveness of the drug, doses of more than 40 mg have not been studied.

    Benign prostatic hyperplasia: The maintenance dose is usually 5-10 mg once a day. At present, there are no data showing an additional symptomatic effect in a dose of the drug above 10 mg per day.

    In elderly patients and patients with renal insufficiency, dose adjustment is not required.

    Side effects:

    From the cardiovascular system: palpitations, tachycardia, orthostatic hypotension, vasodilation .. Not clearly associated with the use of terazosin: arrhythmia.

    From the side of the blood and lymphatic system: thrombocytopenia.

    From the nervous system: fainting, dizziness, drowsiness, headache, paresthesia.

    From the side of the organ of vision: visual impairment, amblyopia, in the case of cataract surgery in patients receiving α 1-blockers, there was a syndrome of intraoperative instability of the iris (IFIS) (see section "Special instructions")

    Not clearly associated with the use of terazosin: atypical vision, conjunctivitis.

    From the side of the organ of hearing and balance: govulation. Not clearly associated with the use of terazosin: ringing in the ears.

    From the respiratory system, chest and mediastinum: znasal congestion, rhinitis, shortness of breath, sinusitis. It is not clearly associated with the use of terazosin: bronchitis, epistaxis, cold symptoms, pharyngitis, coughing.

    From the gastrointestinal tract: nausea. Not clearly associated with the use of terazosin: abdominal pain, constipation, diarrhea, dry mouth, indigestion, flatulence, vomiting.

    From the side of the kidneys and urinary tracts: is not clearly associated with the use of terazosin:

    increased frequency of urination, urinary tract infections and involuntary urination in postmenopausal women.

    From the skin and subcutaneous tissues: is not clearly associated with the use of terazosin: itching, rash, increased sweating.

    From the musculoskeletal and connective tissue: pain in the back, pain in the limbs. Not clearly associated with the use of terazosin: neck pain, shoulder pain,, arthralgia, arthritis, joint disease, myalgia.

    From the endocrine system: increase body mass. It is not clearly associated with the use of terazosin: gout. .

    Complications of a general nature: asthenia, peripheral edema, edema. Not clearly associated with the use of terazosin: chest pain, swelling of the face, fever.

    From the immune system: anaphylactoid reaction.

    Violations of the genitals and breast: impotence, priapism. Disorders of the psyche: decreased libido, depression, increased excitability.

    It is not clearly associated with the use of terazosin: anxiety, insomnia.

    Laboratory indicators:

    In studies, a small but statistically significant decrease in hematocrit, hemoglobin, leukocytes, total protein and albumin was noted. These laboratory data indicate the ability to hemodilution. Treatment with terazosin for up to 24 months did not have a significant effect on the level of prostate-specific antigen (PSA)
    Overdose:

    In the case of severe hypotension, the occurrence of peripheral circulatory insufficiency, first of all it is important to put the patient in a supine position with raised lower limbs. If necessary, in case of shock, it is necessary to appoint plasma-substituting agents, then - vasopressors. It should, maintain the water and electrolyte balance. Dialysis may not be effective, because terazosin largely binds to plasma proteins.

    Interaction:

    According to clinical studies in patients with BPH receiving tarazosin in combination with an ACE inhibitor or diuretics, the proportion of dizziness or concomitant side effects were higher than in the general population of patients receiving terazosin.

    A special precaution should be observed when terazosin is used with other antihypertensive drugs to prevent the occurrence of significant hypotension. When Terazosin is added to therapy with diuretics or antihypertensive drugs, a dose reduction or re-titration may be required. Adsorbents and antacids reduce absorption. Adrenostimulators weaken the effect. Non-steroidal anti-inflammatory drugs (especially indomethacin) - it is possible to reduce the hypotensive effect due to suppression of synthesis Pg and / or fluid retention and Na +. There are reports of the occurrence of hypotension with simultaneous administration of terazosin with phosphodiesterase-5 inhibitors (PDE-5). The concomitant treatment with terazosin and sildenafil or vardenafil should be started if the patient's condition is stable background of terazosin. Besides, vardenafil should not be taken within 6 hours of taking terazosin, and sildenafil - within 4 hours of taking terazosin.
    Special instructions:

    Like other antagonists of alpha-adrenergic receptors, terazosin It is not recommended to appoint patients with syncope during urination in the anamnesis.

    After the first dose and the first days of therapy, the "first dose" effect may develop: a marked drop in blood pressure, in particular, orthostatic hypotension (with dizziness, sensation of loss of consciousness, fainting). Hypovolemia and restriction of salt intake increase the risk of the effect of the first dose. The same phenomenon can be observed with the resumption of treatment after several days of interruption, therefore, in such cases, the initial dose should be re-applied. The frequency of fainting is approximately 1% of cases. In addition to the effect of the "first dose", too rapid increase in the dose and simultaneous use of diuretics and other antihypertensive drugs can also cause syncope. Syncope, as a rule, is due to pronounced orthostatic hypotension, but it can also be associated with tachycardia (120-160 beats / min). Orthostatic hypotension is most pronounced soon after taking the drug, and the risk of developing fainting is highest between the 30th and 90th minutes after taking the drug. Change of position from the horizontal position or sitting position, long stay in standing position, intense physical load,high ambient temperatures and simultaneous intake of alcohol can provoke dizziness, a sense of insecurity, or even loss of consciousness. If the patient faints, it should be laid with raised lower limbs, and if necessary, apply other variants of symptomatic therapy. When terazosin is used together with diuretics and / or other antihypertensive agents, its dose should be reduced. To avoid severe hypotension, it is recommended to begin treatment with the concomitant drug also with low doses and to conduct careful medical supervision of the patient. The same precautions are necessary when adding terazosin to current diuretic therapy or antihypertensive therapy. The initial dose of terazosin in these cases is also 1 mg.

    In elderly patients, sensitivity to the hypotensive effect of terazosin may be increased. The use of terazosin requires extreme caution in patients with a predisposition to orthostatic hypotension, ischemic heart disease, other severe heart diseases, cerebral circulation, grade III or IV hypertensive retinopathy, insulin-dependent diabetes, and impaired hepatic and renal function.Before the beginning of terazosin treatment of benign prostatic hyperplasia, prostatic carcinoma should be excluded. The patient's blood pressure should be measured regularly at the beginning of treatment with hypertrophy of the prostate with terazosin, in the case of additional therapy, with increasing the dose; also should take into account simultaneously taken antihypertensive drugs. The effectiveness of terazosin in benign prostatic hyperplasia can be assessed only after 4-6 weeks of maintenance dose. In the case of an operation to remove cataracts, patients who received prior alpha-1 blockers experience intraoperative iris of the irisIFIS). This phenomenon is a variant of the narrow pupil syndrome, in which the iris relaxes to such an extent that it becomes unstable during irrigation.

    Despite the preoperative dilatation of the pupil, usually with the help of mydriatic means, the miosis intensifies, and the iris sags toward the phacoemulsification incisions. In such cases, the operating surgeon should be prepared to change the technique of the operation,You may need to use a hook for the iris-coated shell, iris retractor and viscoelastic substances. Preoperative. interruption of therapy αl-blockers has no advantage compared to the continuation of therapy.

    Tablets contain lactose monohydrate (55 mg or 110 mg), so patients with galactose intolerance, lactase deficiency, or with glucose malabsorption syndrome and galactose should not take this drug.

    Effect on the ability to drive transp. cf. and fur:There may be dizziness, a sense of loss of consciousness and fainting, especially in the first days of taking the drug, with an increase in dose or with the resumption of therapy - with Segetis. Patients should be warned about possible side effects and situations when they may appear, and they should be advised to refrain from driving or engaging in potentially hazardous activities for about 12 hours after taking the initial dose or increasing the dose. Later in the treatment process, the degree of limitations should be set for each patient individually.
    Form release / dosage:

    Tablets 1 mg, 2 mg, 5 mg, 10 mg. For 10 tablets in a blister of PVC / PVDC / / aluminum foil.3 blisters together with instructions for use in a cardboard bundle.

    Packaging:tablets, 1 mg, 2 mg, 5 mg, 10 mg (blister) 10 x 3 (a pack of cardboard)
    Storage conditions:Store at temperatures between 15 and 30 ° C out of the reach of children.
    Shelf life:3 years. Do not use after the expiration date indicated on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:П N012256 / 01
    Date of registration:23.08.2010
    The owner of the registration certificate:EGIS ZAO Pharmaceutical Plant EGIS ZAO Pharmaceutical Plant Hungary
    Manufacturer: & nbsp
    Representation: & nbspEGIS ZAO Pharmaceutical Plant EGIS ZAO Pharmaceutical Plant Hungary
    Information update date: & nbsp18.09.2015
    Illustrated instructions
      Instructions
      Up